MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problem Material Puncture/Hole (1504)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

On (b)(6) 2022, it was reported a patient was on antibiotics due to peritonitis.The cause was reported as a hole in the patients pd catheter (not a fresenius product).The patient underwent pd catheter surgery on (b)(6) 2022.The patient was continuing to complete pd therapy utilizing the liberty select cycler.The date of the peritonitis diagnosis was unknown.Attempts to obtain additional information were unsuccessful.C-922894 (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524389
• MDR Text Key: 321134317
• Report Number: MW5131336
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1